PERFOROMIST® (formoterol fumarate) Inhalation Solution

IndicationPERFOROMIST Inhalation Solution is used long term, twice a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD. PERFOROMIST is for inhalation use only through a standard jet nebulizer connected to an air compressor and should not be swallowed or injected.

IMPORTANT SAFETY INFORMATION

People with asthma who take long –acting beta2adrenergic agonist (LABA) medicines such as PERFOROMIST have an increased risk of death from asthma problems. It is not known whether LABA medicines, such as PERFOROMIST, increase the risk of death in people with COPD. Get emergency medical care if breathing problems worsen quickly, or you use your rescue inhaler medicine but it does not relieve your breathing problems

PERFOROMIST should not be used in children.

PERFOROMIST is not for use to treat sudden symptoms of COPD and should not be used more than twice a day. Always have a short-acting beta2-agonist with you treat sudden symptoms.

Tell your health care professional about all of your health conditions, including if you:

have heart problems

have high blood pressure

have diabetes

have seizures

have thyroid problems

have liver problems

are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.

are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Tell your health care professional about all medicines you take including prescription and non-prescription medications, vitamins, and herbal supplements. PERFOROMIST and certain medicines may interact with each other and cause serious side effects.

Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.

Chest pain

Increased or decreased blood pressure

A fast and irregular heartbeat

Low blood potassium

High blood sugar

High blood acid

The most common side effects of PERFOROMIST include:

Headache

Tremor

Nervousness

Dry mouth

Muscle cramps

Nausea, vomiting

Diarrhea

Dizziness

Trouble sleeping

If your COPD symptoms worsen over time do not increase your dose of PERFOROMIST, instead call your health care professional.

Please see accompanying full Prescribing Information, including Boxed Warning.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

ULTIVA® (remifentanil HCI)

As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures

For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting

As an analgesic component of monitored anesthesia care in adult patients

Important Safety Information
Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated.

Vital signs and oxygenation must be continually monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, tachycardia, bradycardia, hypotension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continual monitoring is necessary. ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response. Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min.

Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.

Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs.

ULTIVA SHOULD BE USED IN THE CAREFULLY MONITORED SETTINGS BY SPECIFICALLY TRAINED PERSONS NOT INVOLVED IN THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION IS TO BE CONTINUOUSLY MONITORED. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE.

EMSAM® (selegiline transdermal system)

IndicationEMSAM® (selegiline transdermal system) is a skin patch used to treat major depressive disorder.

Suicidality and Antidepressant Drugs
Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed. Call a health care professional right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms. EMSAM Transdermal System is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about EMSAM?

Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults

Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed.

Call a healthcare provider right away to report any new or sudden changes in mood, behavior, thoughts, or feelings.

Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms.

EMSAM Transdermal System is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.

Call a health care professional right away if you, or someone you care for, have any of the following symptoms, especially if they are new, worse or worry you:

thoughts about suicide or dying

attempts to commit suicide

new or worse depression

new or worse anxiety

feeling agitated, restless, angry or irritable

panic attacks

trouble sleeping

new or worse irritability

acting aggressive, being angry or violent

acting on dangerous impulses

an extreme increase in activity or talking (mania)

other unusual changes in behavior or mood

Who should not use EMSAM?Using EMSAM with certain antidepressants and certain pain, cold and cough symptom medicines may cause a potentially life-threatening problem called serotonin syndrome (See “What are the possible side effects of EMSAM?”).

Ask your health care professional or pharmacist if you are not sure if you take these medicines.

What should I tell my doctor before starting EMSAM Transdermal System?

Tell your health care professional if you:

have high blood pressure

have or had mania or bipolar disorder (manic depression)

have or had seizures or convulsions

drink alcohol

have any other medical conditions

are or intend to become pregnant

are breastfeeding or intend to breastfeed

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. EMSAM and some medicines may interact with each other, may not work as well or may cause serious side effects when taken together.

In particular, tell your health care professional if you take:

other medicines to treat depression (antidepressants) including other MAOI medicines

decongestant medicines to treat cold or cough symptoms

over-the-counter diet pills or herbal weight-loss products

any herbal or dietary supplement that contains tyramine and/or medicines called stimulants or uppers (amphetamines)

buspirone, an anxiety medicine

Some of these medicines need to be stopped for at least 1 week before you can start using EMSAM and for 2 weeks after you stop using EMSAM. Ask your health care professional or pharmacist if you are not sure if you take these medicines. Know the medicines you take. Keep a list of them to show your health care professional or pharmacist when you get a new medicine.

Do not eat foods or drink beverages that contain high amounts of tyramine (e.g. aged and fermented meats, broad bean pods, aged cheese, all tap beers, most soybean products and over-the-counter supplements containing tyramine) while using EMSAM 9 mg or EMSAM 12 mg or for 2 weeks after you stop using EMSAM 9 mg or EMSAM 12 mg. You do not have to make any diet changes when you use EMSAM 6 mg. Ask your health care professional or see the Medication Guide for a complete list of foods and drinks that must be avoided.

Do not drive, operate heavy machinery or do other dangerous activities until you know how EMSAM affects you.

You should not drink alcohol while using EMSAM.

What are the possible side effects of EMSAM? EMSAM may cause serious side effects, including:

See “What is the most important information I should know about EMSAM?”

If you suddenly have these symptoms, go to the nearest hospital emergency room right away.

A sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drink certain beverages while you use EMSAM. A hypertensive crisis can lead to stroke and death. See “What should I avoid while using EMSAM?

A hypertensive crisis can also happen if you use EMSAM with certain other medicines. See “Who should not use EMSAM?”

Symptoms of a hypertensive crisis include: sudden, severe headache; nausea; vomiting; stiff or sore neck; a fast heartbeat (palpitations) or a change in the way your heart beats; excessive sweating sometimes with fever or cold, clammy skin; the pupils in your eyes increase in size; light bothers your eyes; fast or slow heart beat with chest pain; and bleeding in your brain. If you suddenly have these symptoms, go to the nearest hospital emergency room right away.

Mania or hypomania (manic episodes) in people who have a history of mania. Symptoms of manic episodes include: greatly increased energy; severe problems sleeping; racing thoughts; reckless behavior; excessive happiness or irritability; talking more or faster than usual; and unusually grand ideas

Common side effects in people who use EMSAM include:

a skin reaction where the patch is placed. You may see mild redness at the site when a patch is removed. This redness should go away within several hours after removing the patch. If irritation or itching continues, tell your health care professional.

headache

diarrhea

indigestion

trouble sleeping (insomnia)

dry mouth

rash

sore throat

sinus infection

Tell your health care professional if you have any side effect that bothers you or does not go away. These are not all the side effects of EMSAM. For more information, ask your health care professional or pharmacist.

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